US10687879B2 - Bone material dispensing device - Google Patents
Bone material dispensing device Download PDFInfo
- Publication number
- US10687879B2 US10687879B2 US16/026,574 US201816026574A US10687879B2 US 10687879 B2 US10687879 B2 US 10687879B2 US 201816026574 A US201816026574 A US 201816026574A US 10687879 B2 US10687879 B2 US 10687879B2
- Authority
- US
- United States
- Prior art keywords
- tubular member
- bone material
- housing
- opening
- plunger
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
- A61B17/8822—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4601—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
- A61B2017/00407—Ratchet means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00862—Material properties elastic or resilient
Definitions
- Bone graft is important in orthopedic procedures for the repair of bone defects caused by injury, disease, wounds, or surgery.
- a number of materials have been used or proposed for use in the repair of bone defects.
- the biological, physical, and mechanical properties of the materials are among the major factors influencing their suitability and performance in various orthopedic applications.
- Bone tissue regeneration is achieved by filling a bone defect with a bone material, for example, a bone graft. Over time, the bone graft is incorporated by the host and new bone remodels the bone graft.
- Bone material can include bone from the patient's own body, synthetic bone material, natural substitute bone material or combinations thereof.
- the bone material is mixed with liquid or a therapeutic agent, powder, fiber or granular material.
- transfer of bone material to the dispensing device is often done by crude and messy packing of the bone dispensing device which can cause unwanted waste and spillage of bone material.
- these devices can also increase the risk of contamination of the bone material.
- some dispensing devices can cause damage to surrounding tissue of a surgical site during administration of the bone material.
- bone material can clog certain dispensing devices due to its consistency and/or due to the design of the dispensing device and the amount of bone material cannot be controlled effectively when this occurs.
- a bone material dispensing device that reduces the risk of contamination and spillage of bone material from the dispensing device, administers the bone material to a bone defect and the devices and methods provided reduce clogging during incremental dispensing of the bone material.
- a bone material dispensing device which comprises a housing having a proximal end, a distal end, and a longitudinal axis.
- the proximal end has a first opening and the distal end has a second opening.
- the first opening and the second opening are configured to slidably receive at least a portion of a plunger.
- a tubular member is provided that is pivotably connected to the housing and is configured for lateral movement relative to the longitudinal axis of the housing.
- the tubular member comprises a proximal opening, a distal opening and a channel disposed therebetween.
- the proximal opening, the distal opening and the channel of the tubular member are configured to receive at least the portion of the plunger.
- the tubular member is movable in a first position to align the proximal opening of the tubular member with the second opening of the housing to allow the tubular member to receive at least the portion of the plunger to dispense the bone material.
- a bone material dispensing gun comprising a housing having a proximal end and a distal end, and a longitudinal axis.
- the proximal end has a first opening and the distal end has a second opening.
- the first opening and the second opening are configured to slidably receive at least a portion of a plunger.
- the housing comprises a trigger assembly configured to allow incremental slidable movement of the plunger to dispense the bone material.
- a tubular member is provided that is pivotably connected to the housing and is configured for lateral movement relative to the longitudinal axis of the housing.
- the tubular member comprises a proximal opening, a distal opening and a channel disposed therebetween.
- the proximal opening, the distal opening and the channel of the tubular member are configured to receive at least the portion of the plunger.
- the tubular member is movable in a first position to align the proximal opening of the tubular member with the second opening of the housing to allow the tubular member to receive at least the portion of the plunger to dispense the bone material.
- the tubular member is movable in a second position to misalign the proximal opening of the tubular member with the second opening of the housing to prevent the tubular member from receiving at least the portion of the plunger.
- a method of implanting a bone material comprises loading a bone material dispensing device with the bone material, the bone material dispensing device comprising a housing having a proximal end, a distal end, and a longitudinal axis, the proximal end having a first opening and the distal end having a second opening, the first opening and the second opening configured to slidably receive at least a portion of a plunger; and a tubular member pivotably connected to the housing and configured for lateral movement relative to the longitudinal axis of the housing, the tubular member comprising a proximal opening, a distal opening and a channel disposed therebetween, the proximal opening, the distal opening and the channel of the tubular member configured to receive at least the portion of the plunger, the tubular member being movable in a first position to align the proximal opening of the tubular member with the second opening of the housing to allow the tubular member to receive at least the portion of the plunger to
- FIG. 1 is a perspective view of a bone material dispensing device according to an aspect of the present application.
- the bone material dispensing device includes a housing having a proximal end having a first opening, a distal end having a second opening, and a longitudinal axis.
- the first opening and the second opening are configured to slidably receive at least a portion of a plunger.
- a tubular member is provided that is pivotably connected to the housing and is configured for lateral movement relative to the longitudinal axis of the housing and is configured to receive at least the portion of the plunger for dispensing the bone material.
- FIG. 2 is a partially cross sectioned perspective view of the bone material dispensing device of FIG. 1 .
- the first opening and the second opening of the housing is shown as well as the plunger.
- FIG. 3 is a partially cross sectioned enlarged side view of the bone material dispensing device of FIG. 1 with a portion of the housing removed to show operation and movement of the bone material dispensing device and plunger.
- FIG. 4 is a partially cross sectioned enlarged side view of the bone material dispensing device of FIG. 1 with a portion of the housing removed to show operation and movement of the bone material dispensing device and plunger.
- FIG. 5 is a partially cross sectioned enlarged side view of the bone material dispensing device of FIG. 1 with a portion of the housing removed to show operation and movement of the bone material dispensing device and plunger.
- FIG. 6 is a partially cross sectioned enlarged side view of the bone material dispensing device of FIG. 1 with a portion of the housing removed to show operation and movement of the bone material dispensing device and plunger.
- FIG. 7 is a partially cross sectioned enlarged side view of the bone material dispensing device of FIG. 1 with a portion of the housing removed to show operation and movement of the bone material dispensing device and plunger.
- FIG. 8 is a perspective view of the bone material dispensing device of FIG. 1 showing movement of the tubular member in a first position to align the proximal opening of the tubular member with the second opening of the housing to allow the tubular member to receive at least the portion of the plunger to dispense the bone material.
- FIG. 9 is a perspective view of the bone material dispensing device of FIG. 1 engaged with a cannula and a funnel portion configured to partially enclose the tubular member.
- FIG. 10 is a perspective view of the bone material dispensing device of FIG. 1 where the housing comprises a locking member to lock the funnel portion to the housing.
- the cannula and the funnel portion are shown as a cross sectional view.
- FIG. 11 is a perspective view of the bone material dispensing device of FIG. 1 and the cannula comprising a funnel shown in FIG. 9 before the cannula and funnel engage the bone material dispensing device.
- an end of the cannula is shown disposed with a vertebral disc for administration of the bone material.
- the cannula and the funnel portion are shown as a cross sectional view.
- FIG. 12 is a perspective view of the bone material dispensing device of FIG. 1 engaged with the cannula comprising a funnel shown in FIG. 9 .
- an end of the cannula is shown disposed with a vertebral disc for administration of the bone material.
- the cannula and the funnel portion are shown as a cross sectional view.
- FIG. 13 is a perspective view of the bone material dispensing device of FIG. 1 engaged with the cannula comprising a funnel shown in FIG. 9 .
- an end of the cannula is shown disposed with a vertebral disc and movement of the trigger assembly for administration of the bone material.
- the cannula and the funnel portion are shown as a cross sectional view.
- FIG. 14 is a partially cross sectioned perspective view of the bone material dispensing device of FIG. 1 engaged with the cannula comprising a funnel shown in FIG. 9 .
- an end of the cannula is shown disposed with a vertebral disc and movement of the plunger for administration of the bone material.
- the cannula and the funnel portion are shown as a cross sectional view.
- FIG. 15 is a partially cross sectioned perspective view of the bone material dispensing device of FIG. 1 engaged with the cannula and a funnel portion shown in FIG. 9 .
- an end of the cannula is shown disposed with a vertebral disc and movement of the trigger assembly moves the plunger for administration of the bone material.
- the cannula and the funnel portion are shown as a cross sectional view.
- FIG. 16 is a partially cross sectioned perspective view of the bone material dispensing device of FIG. 1 engaged with the cannula comprising a funnel shown in FIG. 9 .
- movement of the passive pawl is shown for ejecting the plunger from the bone material dispensing device.
- the cannula and the funnel portion are shown as a cross sectional view.
- FIG. 17 is a perspective view of a folding cannula.
- the folding cannula includes an upper compartment, a lower compartment, and a fold line.
- the folding cannula is shown in an unfolded configuration.
- FIG. 18 is a perspective view of the folding cannula of FIG. 17 .
- the folding cannula is shown in a folded configuration.
- FIG. 19 is a perspective view of the folding cannula of FIG. 17 loaded into the housing and into the tubular member.
- FIG. 20 is a perspective view of the bone material dispensing device of FIG. 1 engaged with the folding cannula of FIG. 17 comprising a funnel.
- a distal end of the folding cannula is shown disposed in a vertebral disc and the funnel portion partially encloses the tubular member. In this view, the plunger is not loaded in the device.
- FIG. 21 is a partially cross sectioned perspective view of the bone material dispensing device of FIG. 1 engaged with the folding cannula of FIG. 17 comprising a funnel.
- an end of the cannula is shown disposed with a vertebral disc and movement of the trigger assembly moves the plunger for administration of the bone material.
- FIG. 22 is a partially cross sectioned perspective view of the bone material dispensing device of FIG. 1 engaged with the folding cannula of FIG. 17 comprising a funnel.
- an end of the cannula is shown disposed with a vertebral disc and movement of the trigger assembly moves the plunger for administration of the bone material.
- raft refers to a graft of tissue obtained from a donor of the same species as, but with a different genetic make-up from, the recipient, as a tissue transplant between two humans.
- autologous refers to being derived or transferred from the same individual's body, such as for example an autologous bone marrow transplant.
- xenograft refers to tissue or organs from an individual of one species transplanted into or grafted onto an organism of another species, genus, or family.
- mammal refers to organisms from the taxonomy class “mammalian,” including, but not limited to, humans; other primates, such as chimpanzees, apes, orangutans and monkeys; rats, mice, cats, dogs, cows, horses, etc.
- a biological system can include, for example, an individual cell, a set of cells (e.g., a cell culture), an organ, or a tissue. Additionally, the term “patient” can refer to animals, including, without limitation, humans.
- bone material includes natural and/or inorganic material such as, for example, inorganic ceramic and/or bone substitute material.
- the bone material can also include natural bone material such as, for example, bone which is cortical, cancellous or cortico-cancellous of autogenous, allogenic, xenogenic, or transgenic origin.
- bone material can include demineralized bone material such as, for example, substantially demineralized bone material, partially demineralized bone material, or fully demineralized bone material.
- Demineralized refers to any material generated by removing mineral material from tissue, e.g., bone tissue.
- the demineralized compositions described herein include preparations containing less than 5% calcium and preferably less than 1% calcium by weight.
- Partially demineralized bone e.g., preparations with greater than 5% calcium by weight but containing less than 100% of the original starting amount of calcium
- demineralized bone has less than 95% of its original mineral content.
- demineralized bone has less than 95% of its original mineral content. In some embodiments, demineralized bone has less than 95, 94, 93, 92, 91, 90, 89, 88, 87, 86, 85, 84, 83, 82, 81, 80, 79, 78, 77, 76, 75, 74, 73, 72, 71, 70, 69, 68, 67, 66, 65, 64, 63, 62, 61, 60, 59, 58, 57, 56, 55, 54, 53, 52, 51, 50, 49, 48, 47, 46, 45, 44, 43, 42, 41, 40, 39, 38, 37, 36, 35, 34, 33, 32, 31, 30, 29, 28, 27, 26, 25, 24, 23, 22, 21, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6 and/or 5% of its original content. In some embodiments, “demineralized” is intended to encompass such expressions as “substantially demineralized,”
- Partially demineralized is intended to encompass “surface demineralized.” “Partially demineralized bone” is intended to refer to preparations with greater than 5% calcium by weight but containing less than 100% of the original starting amount of calcium.
- partially demineralized comprises 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95,
- the demineralized bone may be surface demineralized from about 1-99%.
- the demineralized bone is 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98 and/or 99% surface demineralized.
- the demineralized bone may be
- Superficially demineralized refers to bone-derived elements possessing at least about 90 weight percent of their original inorganic mineral content
- the expression “partially demineralized” as used herein refers to bone-derived elements possessing from about 8 to about 90 weight percent of their original inorganic mineral content
- the expression “fully demineralized” as used herein refers to bone containing less than 8% of its original mineral context.
- DBM compositions as used herein refers to any material generated by removing mineral material from bone tissue.
- the DBM compositions as used herein include preparations containing less than 5% calcium and preferably less than 1% calcium by weight.
- Biocompatible refers to materials that, upon administration in vivo, do not induce undesirable long-term effects.
- Osteoconductive refers to the ability of a non-osteoinductive substance to serve as a suitable template or substance along which bone may grow.
- Ostogenic refers to the ability of an agent, material, or implant to enhance or accelerate the growth of new bone tissue by one or more mechanisms such as osteogenesis, osteoconduction, and/or osteoinduction.
- Ostoinductive refers to the quality of being able to recruit cells from the host that have the potential to stimulate new bone formation. Any material that can induce the formation of ectopic bone in the soft tissue of an animal is considered osteoinductive. For example, most osteoinductive materials induce bone formation in athymic rats when assayed according to the method of Edwards et al., “Osteoinduction of Human Demineralized Bone: Characterization in a Rat Model,” Clinical Orthopaedics & Rel. Res., 357:219-228, December 1998, incorporated herein by reference.
- removably engage includes engagement of two or more components that can be used or combined into one element via the engagement of the two or more elements with a connecting means, a locking means, or by placing the elements tightly together.
- the two or more elements may be positioned adjacent to each other and each include a contacting surface.
- a bone material dispensing device 30 is provided that is used to administer bone material to a surgical site in incremental amounts, as shown in FIGS. 1-22 .
- the bone material dispensing device can be a bone material dispensing gun that reduces the risk of contamination and spillage of bone material from the dispensing device, and administers the bone material to a surgical site (e.g., bone defect) while reducing damage to surrounding tissue.
- the bone material dispensing device reduces clogging and allows incremental dispensing of the bone material.
- the bone material dispensing device is also configured for left handed and right handed use.
- a surgical site can include, but is not limited to injury, defects brought about during the course of surgery, infection, malignancy or developmental malformation.
- Specific bones which can be repaired or replaced with the bone material can include, but are not limited to the ethmoid; frontal; nasal; occipital; parietal; temporal; mandible; maxilla; zygomatic; cervical vertebra; thoracic vertebra; lumbar vertebra; sacrum; rib; sternum; clavicle; scapula; humerus; radius; ulna; carpal bones; metacarpal bones; phalanges; ilium; ischium; pubis; femur; tibia; fibula; patella; calcaneus; tarsal and metatarsal bones.
- the bone material dispensing device administers bone material to at least a portion of the spinal cord such as vertebrae or a vertebra V1, as shown in FIG. 11 .
- the bone material dispensing device includes a housing 32 having a proximal end 34 , a distal end 36 , and a longitudinal axis AA disposed therebetween.
- the proximal end of the housing includes a first opening 38 and the distal end includes a second opening 40 .
- the first opening and the second opening are configured to slidably receive at least a portion of a plunger 42 , as described herein.
- the first opening has a diameter D1 and the second opening has a diameter D2, as shown in FIGS. 4 .
- D1 and D2 are the same diameter.
- D1 and D2 can have different diameters.
- the diameters D1 and D2 can be from about 2 millimeters (mm) to about 40 mm.
- the diameters can be from about 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38 to about 40 mm.
- the first and second openings can be shaped and can be round, oval, rectangular or square.
- the plunger as described herein, has a proximal end 44 and a distal end 46 .
- the plunger is configured to assist in the dispensing/administration of the bone material to a surgical site, as described herein. This allows for controlled and incremental administration of the bone material to the bone defect.
- the proximal end or the distal end of the plunger can include a rim and/or a pushplate to assist in dispensing the bone material.
- the diameter D3 of the plunger is smaller than diameters D1 and D2, as shown in FIG. 3 . In some embodiments, the diameter D3 of the plunger is slightly smaller than diameters D1 and D2 but allows at least a portion of the plunger to slide within the openings.
- diameter D3 can be from about 2 millimeters (mm) to about 36 mm.
- the diameter D3 can be from about 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34 to about 36 mm.
- the plunger can also have a certain length L1 of from about 1 to about 20 inches, as shown in FIG. 14 .
- the length L1 of the plunger can be from about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 to about 20 inches.
- the plunger length can be smaller, larger or the same size as the cannula, as described herein.
- the plunger can be flexible or rigid.
- the bone material dispensing device includes a tubular member 48 that is pivotably connected to the housing and is configured for lateral movement relative to longitudinal axis AA of the housing.
- the tubular member includes a proximal end 50 , a distal end 52 and longitudinal axis AA is disposed therebetween when the tubular member is in a first position, as described herein.
- the tubular member can be conical and the distal end can be tapered.
- the proximal end of the tubular member includes a proximal opening 54 and the distal end of the tubular member includes a distal opening 56 .
- a channel 58 is disposed therebetween.
- the proximal opening, the distal opening and the channel of the tubular member are configured to receive at least a portion of the plunger such that when bone material is disposed within the channel, the plunger can be advanced into the channel to dispense or administer the bone material, as described herein.
- the tubular member is movable in a first position to align the proximal opening of the tubular member with the second opening of the housing to allow the tubular member to receive at least the portion of the plunger (as shown in FIGS. 3 and 4 ) to dispense the bone material.
- the tubular member is also movable in a second position to misalign the proximal opening of the tubular member with the second opening of the housing to prevent the tubular member from receiving at least the portion of the plunger.
- the tubular member is pivotably connected to the housing via a pivot point, such as a hinge 60 .
- the hinge is transverse relative to longitudinal axis AA.
- the hinge facilitates rotation of the tubular member relative to the housing in the directions shown by arrows A and B, shown in FIG. 8 .
- the hinge can alternatively be or can include a pivot pin, or a rod.
- the tubular member pivots towards and away from the housing at an angle ⁇ 1 of from about 2 to about 180 degrees, as shown in FIG. 8 .
- al is from about 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90, 92, 94, 96, 98, 100, 102, 104, 106, 108, 110, 112, 114, 116, 118, 120, 122, 124, 126, 128, 130, 132, 134, 136, 138, 140, 142, 144, 146, 148, 150, 152, 154, 156, 158, 160, 162, 164, 166, 168, 170, 172, 174, 176, 178 to about 180 degrees.
- the tubular member can be pivoted so that there is enough space provided for the tubular member to be loaded with bone material.
- the tubular member locks with a portion of the distal end of the housing via a detent 62 that is located between the tubular member and the housing.
- the detent locks the tubular member in the first position, as described above.
- the detent can be a catch, a lever, a spring, a hinged catch that engages a notch of a ratchet, or a combination thereof.
- the locking will allow the openings to align (as shown in FIG. 10 ) and the plunger to be slid through the openings.
- the holes are misaligned and the plunger cannot be slid through the tubular member, as shown in FIG. 8 .
- the tubular member In some embodiments, the tubular member can be entirely detachable and can snap connect to the housing. In some embodiments, the tubular member can be entirely detachable and connect with a screw-on thread form to the housing. In some embodiments, the tubular member can be pivotably connected to the housing in a similar manner to a breach loaded shot-gun. It should be noted that one of ordinary skill in the art can modify the tubular member and its connection to the housing to adjust the design of the bone material dispensing device.
- the housing includes a trigger assembly 64 , as shown in FIG. 1 that is configured to allow incremental slidable movement of the plunger to dispense the bone material, as described herein.
- the trigger assembly includes a driving handle 66 and a stationary handle 68 .
- the driving handle includes a proximal end 70 , a distal end 72 and a longitudinal axis BB disposed therebetween.
- the proximal end of the driving handle is configured for pivotable engagement with an intermediate portion of the stationary handle and a proximal end of a driving pawl, as described below.
- the proximal end of the driving handle includes an extension 74 , as shown in FIG. 4 .
- the extension has an angle ⁇ 2 , as shown in FIG. 4 .
- the extension can have an angle ⁇ 2 from about 20 to about 50 degrees. In some embodiments, the extension can have an angle ⁇ 2 of from about 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 to about 50 degrees.
- the extension is configured for engagement with a proximal end of a driving pawl, as described below.
- the proximal end of the driving handle includes a recess 76 that is distal to the extension.
- the recess is configured for engagement with a pin 78 such that the proximal end of the driving handle pivotable engages with the stationary handle, as described herein.
- a surface 80 of the driving handle includes gripping surfaces 82 and a projection 84 , as shown in FIG. 8 .
- the gripping surfaces and the projection are configured for engagement with a user's hand such that the driving handle can be controlled effectively by the user.
- the gripping surfaces can be raised or straight and the projection can be curved or straight.
- the gripping surface can also be roughened to increase the control that the user has over the driving handle.
- the surface of the driving handle can also define cutouts 86 .
- the cutouts can be oval, round, square, triangular, rectangular or any other regular or irregular shape.
- the stationary handle includes a proximal end 88 , an intermediate portion 90 , a distal end 92 and a longitudinal axis CC disposed between the proximal end and the distal end.
- the proximal end of the stationary handle includes a first side 94 , a second side 96 and a third side 98 .
- the first, second and third sides are part of the housing.
- the proximal end of the stationary handle can be monolithic with the housing and the first, second and third sides can be monolithic or fixed to the stationary handle. Portions of the first side and the second side form part of hinge 60 , as shown in FIGS. 1 and 10 .
- the third side includes a slot 100 that is configured for engagement with a portion of a passive pawl, as described herein and shown in FIG. 9 .
- the intermediate portion of the stationary handle is configured for engagement with the proximal end of the driving handle.
- a recess 102 as shown in FIG. 3 is formed in the intermediate portion and is configured for engagement with pin 78 , as shown in FIG. 5 such that the proximal end of the driving handle pivotable engages with the stationary handle, as described herein and shown in FIG. 3 .
- the driving handle pivots toward and away from the stationary handle at an angle ⁇ 3 of from about 1 to about 60 degrees, shown in FIGS. 4 and 11 .
- ⁇ 3 is from about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59 to about 60 degrees.
- a recess 104 is formed in a portion of the second side of the stationary handle and is configured for engagement with a pin 106 such that a passive pawl can pivotably engage with the housing, as described herein and shown in FIGS. 4-7 .
- the stationary handle and the housing are monolithic with one another. In some embodiments, the stationary handle and the housing are not monolithic.
- the trigger assembly of the housing further includes a driving pawl 108 and a passive pawl 110 .
- the driving pawl is configured to work in conjunction with a resilient member to assist the stationary handle and the driving handle in incremental slideable movement of the plunger such that the plunger dispenses the bone material.
- the resilient member shown as a spring is concentric with the plunger. On movement of the driving handle to the stationary handle, the spring is compressed and the stored energy pushes the plunger longitudinally in increments.
- the driving pawl is disposed at one end of the resilient member and the other end of the resilient member biases against the housing and plunger.
- the driving pawl includes a first end 112 and a second end 114 , as shown in FIGS. 3-7 .
- the first end of the driving pawl is configured for movable engagement with the extension of the driving handle.
- the first end of the driving pawl can have a concave portion 116 that engages with the extension of the driving handle.
- the driving pawl includes a third opening 118 that is in alignment and in between the first opening and the second opening of the housing, as shown in FIG. 2 .
- the third opening is configured to slidably receive at least a portion of the plunger 42 , as described herein.
- the third opening can be centrally located on the driving pawl.
- the third opening has a diameter D4, as shown in FIG. 5 .
- D4 can be the same diameter as D1 and D2, and D4 has a greater diameter than plunger diameter D3.
- D4 can have a different diameter than D1 and D2.
- diameter D4 can be from about 6 millimeters (mm) to about 40 mm.
- Diameter D4 can be from about 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38 to about 40 mm.
- the third opening can be shaped and can be round, oval, rectangular or square.
- the second end of the driving pawl includes a lever 120 that is configured for slidable engagement with the slot of the third side of the stationary handle.
- the lever can be variously shaped, including but not limited to T-shaped, as shown in FIG. 10 .
- the passive pawl includes a first end 122 , and a second end 124 , as shown in FIG. 6 .
- the passive pawl is configured to work in conjunction with a resilient member to control when the plunger is advanced during dispensing of the bone material and retracted after dispensing or reloading of the bone material.
- the passive pawl allows the plunger to be adjusted so that the plunger can be located adjacent to the bone material and if more bone material is added to the cannula or the tubular member, the plunger can be adjusted to be placed adjacent to the additional bone material. In this way, the bone material dispensing device can easily accommodate various quantities of bone material.
- the first end of the passive pawl can be angled.
- the second end of the passive pawl includes a recess 126 configured for engagement with pin 106 such that the passive pawl can pivotably engage with the housing, as shown in FIGS. 4-7 .
- the passive pawl can pivot at an angle ⁇ 4 of from about 2 to about 45 degrees, as shown in FIG. 6 .
- ⁇ 4 is from about 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 45 or from about 46 degrees.
- the passive pawl includes a fourth opening 128 that is above and in alignment with the first opening and the second opening of the housing, and the third opening of the driving pawl, as shown in FIG. 2 .
- the fourth opening is configured to slidably receive at least a portion of the plunger 42 , as described herein.
- the fourth opening can be centrally located on the passive pawl.
- the fourth opening has a diameter D5, as shown in FIG. 4 .
- D5 can be the same diameter as D1, D2 and D4, and has a greater diameter than plunger diameter D3.
- D5 can have a different diameter than D1, D2 and D4.
- diameter D5 can be from about 6 millimeters (mm) to about 40 mm.
- Diameter D5 can be from about 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38 to about 40 mm.
- the fourth opening can be shaped and can be round, oval, rectangular or square.
- a recess 130 is located on an underside of the passive pawl, shown in FIG. 1 and is configured for engagement with an end of a resilient member, as described herein.
- the recess can be variously shaped, such as, for example, rectangular, round, oval or square.
- the trigger assembly includes a first resilient member, such as a first spring 132 that is configured for engagement with the passive pawl, as described herein.
- the first spring is disposed between a first portion 134 of the housing and the passive pawl, as shown in FIGS. 4 and 5 .
- the first spring comprises a distal end 136 configured for engagement with a stanchion 138 located on the first portion of the housing, and a proximal end 140 which is disposed within recess 130 located on the underside of the passive pawl.
- the first spring is adjacent to the fourth opening or plunger, and can also be concentric to the plunger.
- the first spring can be compressed and store energy, which will allow the plunger to be withdrawn or adjusted to allow bone material to be added to the cannula.
- the trigger assembly includes a second resilient member, such as second spring 142 that is configured for engagement with the driving pawl, as described herein.
- the second spring is disposed concentric to the plunger and is disposed between a second portion 144 of the housing and the driving pawl, as shown in FIG. 4 .
- the second spring comprises a distal end 146 that engages with second opening 40 of the housing, and a proximal end 148 that engages with first opening 38 of the housing. At least a portion of the plunger is configured to be slidably received by the second spring, as described herein.
- the tubular member is configured to engage with a cannula, such as, for example, a folding cannula 150 , as shown in FIG. 17 .
- a cannula such as, for example, a folding cannula 150 , as shown in FIG. 17 .
- the folding cannula is similar to the foldable container found and fully described in U.S. application Ser. No. 15/581,817, of which is owed by Applicant and incorporated fully herein by reference.
- the folding cannula is configured to be loaded with the bone material and engages the tubular member and/or the plunger for dispensing the bone material into a surgical site, as shown in FIGS. 20-22 .
- the folding cannula comprises a proximal end 152 and a distal end 154 .
- the folding cannula is segmented into an upper compartment 156 and a lower compartment 158 , and the folding cannula is movable in a folded configuration ( FIG. 18 ) and an unfolded configuration ( FIG. 17 ) about a fold line 160 .
- the folding cannula has a diameter D6 that is larger than a diameter D7 of distal opening 56 of the tubular member so as to allow at least a portion of the folding cannula to be held within the tubular member, as shown in FIGS. 5, 7 and 19 .
- diameter D6 can be from about 2 millimeters (mm) to about 40 mm.
- the diameter D6 can be from about 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38 to about 40 mm.
- the folding cannula can have differing diameters throughout the folding cannula and does not have to have a uniform diameter.
- the diameter D7 has a larger diameter than the plunger diameter D3.
- the diameter D7 can be from about 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36 to about 38 mm.
- the folding cannula engages with a funnel or funnel portion 162 that is configured to removably engage and partially enclose the tubular member, as shown in FIGS. 10 and 20-22 .
- the funnel portion matingly engages conically with the distal end of the tubular member.
- the funnel portion includes a proximal end 164 and a distal end 166 .
- the proximal end engages with a portion of the housing to lock the funnel portion to the housing via a locking member 168 , as shown in FIG. 10 . It will be understood that shown is a cross sectional view of the cannula and the funnel portion.
- the distal end of the funnel portion can be various dimensions and can be a certain length L2, such as 1 to about 20 inches. In some embodiments, the length of the distal end of the funnel portion can be from about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 to about 20 inches. In some embodiments, a dog-point can be added between the housing and the funnel portion to provide an even more secure engagement between the housing and the funnel portion. In some embodiments, the funnel portion is separate or is a component of the folding cannula. In some embodiments, the funnel portion is flexible or rigid, or only one of the funnel portion or the plunger is flexible.
- the tubular member In operation, to load the bone material dispensing device with bone material, the tubular member is rotated in the direction of arrow B, as shown in FIG. 8 .
- the tubular member is then loaded with the bone material, or the folding cannula is loaded with the bone material and inserted into the proximal end of the tubular member so that at least a portion of the folding cannula is held within the tubular member and at least a portion of the folding cannula is fed through the distal opening of the tubular member, as shown in FIGS. 19-22 .
- the tubular member is then moved about hinge 60 in a first position, as shown by arrow A in FIG. 8 and the funnel portion engages with the tubular member and/or the combination tubular member and the folding cannula.
- the funnel portion is then locked onto the housing via the locking member, as shown in FIG. 10 .
- the funnel can be loaded with the bone material and then locked onto the housing.
- the distal end of the funnel portion is then inserted into a surgical site, such as, for example, vertebra V1, as shown in FIG. 14 .
- the distal end of the funnel portion can be inserted into the surgical site before or after the funnel portion is locked onto the housing, as shown in FIGS. 11 and 12 .
- the funnel portion can be placed at the surgical site first and then locked with the housing. In the first position, the proximal opening of the tubular member is aligned with the second opening of the housing to allow the tubular member to receive at least the portion of the plunger to dispense the bone material.
- the plunger is then translated in the direction of arrow F shown in FIGS. 14 and 15 , into the fourth opening of the passive pawl, the first opening of the housing, the third opening of the driving pawl and the second opening of the housing via the trigger assembly.
- the driving handle of the trigger assembly contacts the first end of the driving pawl, as shown in FIG. 3 , when the driving handle is moved toward the stationary handle in the direction shown by arrow C in FIGS. 13 and 15 , and movement of the driving handle toward the stationary handle causes the driving pawl to compress the second spring in the direction shown by arrow D in FIG. 4 and transient energy from the compressed second spring allows incremental slidable movement of the plunger, as shown by arrow E in FIG. 4 .
- diameter D4 of the third opening of the driving pawl is slightly larger than diameter D3 of the plunger, and the driving pawl is driven off axis using extension 74 of the driving handle, as the driving handle presses downward on the driving pawl it tilts and diameter D4 becomes the same size as diameter D3, pinching the plunger. Any further advancement of the driving handle results in the driving pawl pinching the plunger harder and advancing the plunger. As soon as the pressure on the driving handle is released, the second spring pushes up on the driving pawl again increasing the size of D4, allowing the driving pawl to slide back up the plunger, returning it to the starting position to push again.
- Movement of the driving handle toward the stationary handle also causes the first spring to be compressed against the first portion of the housing by the passive pawl.
- the driving handle is released and the driving handle moves in the direction shown by arrow G of FIG. 16 .
- the proximal end of the passive pawl is then pushed in a downward direction, as shown by arrow H in FIG. 7 to again compress the first spring so that the first spring contains transient energy such that the user can retract the plunger in a proximal direction, as shown by arrow I of FIGS. 7 and 16 .
- the advancement and retraction of the plunger can be controlled by the passive pawl and the first spring.
- the passive pawl pinches the plunger, preventing the plunger from retracting while the driving pawl is returned to its starting position. Further, the passive pawl allows the plunger to move through the fourth opening because the passive pawl pivots and is spring loaded via the first spring.
- the tubular member is also movable in a second position, as shown by FIGS. 8 and 11-12 to misalign the proximal opening of the tubular member with the second opening of the housing to prevent the tubular member from receiving at least the portion of the plunger.
- the bone material dispensing device can be used in conjunction with the products found and fully described in U.S. application Ser. Nos. 15/340,770, and 15/818,395; and U.S. Publication Nos. 2017/0216051, 2018/0078385, 2017/0216045, 2018/0071113, and 2016/0100955, of which are all owned by Applicant and incorporated fully herein by reference.
- various orthopedic implants can be used in conjunction with the bone material dispensing device.
- the folding cannula can be made of a memory shape polymer and/or alloy to allow the folding cannula to move from an unfolded configuration to a folded configuration without the need for a locking mechanism.
- Memory shape polymers include, but are not limited to polyethers, polyacrylates, polyamides, polysiloxanes, polyurethanes, polyethers amides, polyurethane/ureas, polyether esters, polynorborene, cross-linked polymers such as cross-linked polyethylene and cross-linked poly(cyclooctene), inorganic-organic hybrid polymers, and copolymers such as urethane/butadiene copolymers, styrene-butadiene copolymers.
- Memory shape alloys include, but are not limited to TiNi, CuZnAl, and FeNiAl alloys.
- the folding cannula can be fabricated by injection molding of plastic materials comprising rigid, surgical grade plastic and/or metal materials.
- components of the bone material dispensing device may be made from materials, such as for example, polyurethane, polyurea, polyether(amide), PEBA, thermoplastic elastomeric olefin, copolyester, and styrenic thermoplastic elastomer, steel, aluminum, stainless steel, titanium, nitinol, metal alloys with high non-ferrous metal content and a low relative proportion of iron, carbon fiber, glass fiber, plastics, ceramics or combinations thereof.
- the folding cannula, funnel portion, plunger or tubular member may optionally include one or more tapered regions. In various embodiments, these components may be blunt, beveled, diamond point, ball tip, trocar tip, etc.
- the bone material dispensing device can be made from materials that allow the bone material dispensing device to be reusable, or alternatively made from materials that allow for a single, disposable use.
- the shape of the folding cannula may be selected for particular applications.
- Such shape and configuration may include, for example, the basic shape of a folding cannula (e.g., a tubular shaped cannula).
- a method of implanting a bone material comprising loading a bone material dispensing device (e.g., gun) with the bone material, the bone material dispensing device comprising a housing having a proximal end, a distal end, and a longitudinal axis, the proximal end having a first opening and the distal end having a second opening, the first opening and the second opening configured to slidably receive at least a portion of a plunger; and a tubular member pivotably connected to the housing and configured for lateral movement relative to the longitudinal axis of the housing, the tubular member comprising a proximal opening, a distal opening and a channel disposed therebetween, the proximal opening, the distal opening and the channel of the tubular member configured to receive at least the portion of the plunger, the tubular member being movable in a first position to align the proximal opening of the tubular member with the second opening of the housing to allow the tubular member to receive at least the portion of the portion of the bone
- moving the tubular member in a second position to misalign the proximal opening of the tubular member with the second opening of the housing prevents the tubular member from receiving at least the portion of the plunger.
- the driving pawl moves a defined amount. If a translation distance X is multiplied by a diameter of the funnel portion or the cannula, a cylinder of volume can be calculated.
- the bone material dispensing device can be adjusted to dispense a predefined amount of bone material per pivot of the driving handle. In some embodiments, the predefined amount of bone material dispensed from the bone material dispensing device can be of from about 0.25 cc to about 1 cc or from about 0.25 ounces (oz) to about 1 oz.
- the bone material can be dispensed in a quantifiable, controlled and predefined amount of from about 0.25 cc to about 1 cc.
- the bone material may be dispensed in a quantifiable, controlled and predefined amount of from about 0.25, 0.30, 0.35, 0.40, 0.45, 0.50, 0.55, 0.60, 0.65, 0.70, 0.75, 0.80, 0.85, 0.90, 0.95 to about 1 cc.
- the bone material can be dispensed in a quantifiable, controlled and predefined amount of from about 0.25 oz to about 1 oz.
- the bone material may be dispensed in a quantifiable, controlled and predefined amount of from about 0.25, 0.30, 0.35, 0.40, 0.45, 0.50, 0.55, 0.60, 0.65, 0.70, 0.75, 0.80, 0.85, 0.90, 0.95 to about 1 oz.
- the bone material can be mixed with liquid material and optionally a therapeutic agent until a desired consistency of the bone material is achieved (e.g., putty, paste, etc.).
- the bone material can be mixed with a suitable diluent and then loaded.
- the folding cannula may have enough space to allow for the bone material and a volume of diluent to be mixed.
- the diluent includes dextrose, other sugars including but not limited to sucrose, fructose, glucose, lactated ringer's, polyols including but not limited to mannitol, xylitol, sorbitol, maltitol, lactitol, polysaccharides including but not limited to native or pre-gelatinized starch, maltodextrins, cyclodextrins, mineral compounds including but not limited to dicalcium or tricalcium phosphate, either dihydrate or anhydrous, cellulose derivatives including but not limited to microcrystalline cellulose, lactoses either monohydrates thereof or anhydrous, as well as their mixtures such as dicalcium phosphate dihydrate, mannitol, pre-gelatinized maize starch, microcrystalline cellulose and their mixtures, water and/or NaCl (saline).
- dextrose other sugars including but not limited to sucrose, fructose, glucose, lactated ringer'
- the saline is 0.90% saline or 0.45% saline.
- other delivery vehicles can be used for example, D5W (dextrose in 5% water), DSNS (dextrose in5% water and normal saline) and D5W/1/2NS (D5Wand 1 ⁇ 2 normal saline), blood, mesenchymal stem cells, or the like.
- a kit comprising the bone material dispensing device.
- the kit may include additional parts along with the bone material dispensing device including the bone material and other components to be used to administer the bone material (e.g., wipes, needles, syringes, other mixing devices, etc.).
- the kit may include the bone material dispensing device in a first compartment.
- the second compartment may include the bone material.
- the third compartment may include a tray used for loading the bone material dispensing device with the bone material.
- the shape of the tray may be selected for particular applications. Such shape and configuration may include, for example, the basic shape of a tray (e.g., a square shaped box, etc.).
- the tray can be similar to the tray found and fully described in U.S. application Ser. No. 15/581,817, of which is owned by Applicant and incorporated fully herein by reference.
- the fourth compartment may include a vial holding the carrier and any other instruments needed for the delivery.
- a fifth compartment may include gloves, drapes, wound dressings and other procedural supplies for maintaining sterility of the implanting process, as well as an instruction booklet, which may include a chart that shows how to administer the bone material after mixing it.
- a sixth compartment may include needles, additional devices and/or sutures. Each tool may be separately packaged in a plastic pouch that is sterilized.
- a seventh compartment may include an agent for radiographic imaging.
- a cover of the kit may include illustrations of the dispensing/administering procedure and a clear plastic cover may be placed over the compartments to maintain sterility.
- one or more components of the bone material dispensing device is sterilized by radiation in a terminal sterilization step in the final packaging.
- Terminal sterilization of a product provides greater assurance of sterility than from processes such as an aseptic process, which require individual product components to be sterilized separately and the final package assembled in a sterile environment.
- gamma radiation is used in the terminal sterilization step, which involves utilizing ionizing energy from gamma rays that penetrate deeply into the bone material dispensing device.
- Gamma rays are highly effective in killing microorganisms, they leave no residues, nor do they have sufficient energy to impart radioactivity to the apparatus.
- Gamma rays can be employed when the device is in the package and gamma sterilization does not require high pressures or vacuum conditions, thus, package seals and other components are not stressed.
- gamma radiation eliminates the need for permeable packaging materials.
- electron beam (e-beam) radiation may be used to sterilize one or more components of the bone material dispensing device.
- E-beam radiation comprises a form of ionizing energy, which is generally characterized by low penetration and high-dose rates.
- E-beam irradiation is similar to gamma processing in that it alters various chemical and molecular bonds on contact, including the reproductive cells of microorganisms. Beams produced for e-beam sterilization are concentrated, highly-charged streams of electrons generated by the acceleration and conversion of electricity.
- Other methods may also be used to sterilize the bone material dispensing device including, but not limited to, gas sterilization such as, for example, with ethylene oxide or steam sterilization.
- the bone material dispensing device can be used to treat a variety of conditions including osteoporosis, bone fracture repair or healing, dental procedures for which increased bone formation in the jaw is of clinical benefit, repair of craniofacial bone defects induced by trauma or congenital defects such as cleft palate/lip, and a number of other musculoskeletal disorders where native bone growth is inadequate, which will be evident to those of ordinary skill in the art.
- the bone material can be administered to treat open fractures and fractures at high risk of non-union, and in subjects with spinal disorders, including subjects in need of spine fusion (e.g., anterior lumbar interbody fusion, posterior lumbar spinal fusion, and cervical spine fusion) or subjects having degenerative disc disease or arthritis affecting the lumbar and cervical spine.
- spine fusion e.g., anterior lumbar interbody fusion, posterior lumbar spinal fusion, and cervical spine fusion
- the bone material can be demineralized bone material.
- the demineralized bone material can comprise demineralized bone, powder, chips, granules, shards, fibers or other shapes having irregular or random geometries. These can include, for example, substantially demineralized, partially demineralized, or fully demineralized cortical and cancellous bone. These also include surface demineralization, where the surface of the bone construct is substantially demineralized, partially demineralized, or fully demineralized, yet the body of the bone construct is fully mineralized.
- the configuration of the bone material can be obtained by milling, shaving, cutting or machining whole bone as described in, for example, U.S. Pat. No. 5,899,939. The entire disclosure is herein incorporated by reference into the present disclosure.
- the bone material can comprise elongated demineralized bone fibers having an average length to average thickness ratio or aspect ratio of the fibers from about 50:1 to about 1000:1.
- the elongated demineralized bone fibers can be round, spherical, granular, elongated, powders, chips, fibers, cylinders, threads, narrow strips, thin sheets, or a combination thereof.
- the bone material comprises elongated demineralized bone fibers and chips.
- the bone material comprises fully demineralized fibers and surface demineralized chips.
- the ratio of fibers to chips or powders is from about 5, 10, 15, 20, 25, 30, 35, 40, or 45 fibers to about 30, 35, 40, 45, 50, 55, 60, 65, or 70 chips.
- the bone material comprises demineralized bone matrix fibers and demineralized bone matrix chips in a 30:60 ratio. In some embodiments, the bone material comprises demineralized bone matrix fibers and demineralized bone matrix chips in a ratio of 25:75 to about 75:25 fibers to chips.
- the bone material can be an inorganic material, such as an inorganic ceramic and/or bone substitute material.
- exemplary inorganic materials or bone substitute materials include but are not limited to aragonite, dahlite, calcite, brushite, amorphous calcium carbonate, vaterite, weddellite, whewellite, struvite, urate, ferrihydrate, francolite, monohydrocalcite, magnetite, goethite, dentin, calcium carbonate, calcium sulfate, calcium phosphosilicate, sodium phosphate, calcium aluminate, calcium phosphate, hydroxyapatite, alpha-tricalcium phosphate, dicalcium phosphate, ⁇ -tricalcium phosphate, tetracalcium phosphate, amorphous calcium phosphate, octacalcium phosphate, BIOGLASSTM fluoroapatite, chlorapatite, magnesium-substituted tricalcium
- the bone material can comprise mineral particles, which comprise tricalcium phosphate and hydroxyapatite in a ratio of about 80:20 to about 90:10. In some embodiments, the mineral particles can comprise tricalcium phosphate and hydroxyapatite in a ratio of about 70:30 to about 95:5. In some embodiments, the mineral particles can comprise tricalcium phosphate and hydroxyapatite in a ratio of about 85:15.
- the bone material may be seeded with harvested bone cells and/or bone tissue, such as for example, cortical bone, autogenous bone, allogenic bones and/or xenogeneic bone while it is mixed.
- harvested bone cells and/or bone tissue such as for example, cortical bone, autogenous bone, allogenic bones and/or xenogeneic bone while it is mixed.
- the bone material may be mixed with one or more therapeutic agents, for example, an anti-inflammatory agent, an analgesic agent, an osteoinductive growth factor, an antimicrobial agent or a combination thereof.
- Osteoinductive agents include one or more members of the family of Bone Morphogenetic Proteins (“BMPs”). BMPs are a class of proteins thought to have osteoinductive or growth-promoting activities on endogenous bone tissue, or function as pro-collagen precursors.
- BMPs utilized as osteoinductive agents comprise one or more of BMP-1; BMP-2; BMP-3; BMP-4; BMP-5; BMP-6; BMP-7; BMP-8; BMP-9; BMP-10; BMP-11; BMP-12; BMP-13; BMP-15; BMP-16; BMP-17; or BMP-18; as well as any combination of one or more of these BMPs, including full length BMPs or fragments thereof, or combinations thereof, either as polypeptides or polynucleotides encoding the polypeptide fragments of all of the recited BMPs.
- the isolated BMP osteoinductive agents may be administered as polynucleotides, polypeptides, full length protein or combinations thereof.
- the osteoinductive factors are the recombinant human bone morphogenetic proteins (rhBMPs) because they are available in unlimited supply and do not transmit infectious diseases.
- the bone morphogenetic protein is a rhBMP-2, rhBMP-4, rhBMP-7, or heterodimers thereof.
- Recombinant BMP-2 can be used at a concentration of about 0.4 mg/mL to about 10.0 mg/mL, preferably about 1.5 mg/mL.
- the bone material may include or be mixed with one or more members from the TGF- ⁇ superfamily.
- the matrix may include AMH, ARTN, GDF1, GDF10, GDF11, GDF15, GDF2, GDF3, GDF3A, GDF5, GDF6, GDF7, GDF8, GDF9, GDNF, INHA, INHBA, INHBB, INHBC, INHBE, LEFTY1, LEFTY2, MSTN, NODAL, NRTN, PSPN, TGFB1, TGFB2, TGFB3, FGF, basic FGF, VEGF, insulin-like growth factor, EGF, PDGF, nerve growth factor or combinations thereof.
- the bone material may include or be mixed with a therapeutic agent including, but not limited to, IL-1 inhibitors, such Kineret® (anakinra), which is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra), or AMG 108, which is a monoclonal antibody that blocks the action of IL-1.
- IL-1 inhibitors such as Kineret® (anakinra), which is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra), or AMG 108, which is a monoclonal antibody that blocks the action of IL-1.
- the bone material may include or be mixed with therapeutic agents including excitatory amino acids such as glutamate and aspartate, antagonists or inhibitors of glutamate binding to NMDA receptors, AMPA receptors, and/or kainate receptors.
- the bone material may include or be mixed with therapeutic agents to reduce inflammation including but not limited to interleukin-1 receptor antagonists, thalidomide (a TNF- ⁇ release inhibitor), thalidomide analogues (which reduce TNF- ⁇ production by macrophages), quinapril (an inhibitor of angiotensin II, which upregulates TNF- ⁇ ), interferons such as IL-11 (which modulate TNF- ⁇ receptor expression), or aurin-tricarboxylic acid (which inhibits TNF- ⁇ ).
- interleukin-1 receptor antagonists thalidomide (a TNF- ⁇ release inhibitor), thalidomide analogues (which reduce TNF- ⁇ production by macrophages), quinapril (an inhibitor of angiotensin II, which upregulates TNF- ⁇ ), interferons such as IL-11 (which modulate TNF- ⁇ receptor expression), or aurin-tricarboxylic acid (which inhibits TNF- ⁇ ).
- the bone material may include or be mixed with a therapeutic agent including, but not limited to, an analgesic agent.
- analgesic agents include, but are not limited to, acetaminophen, tramadol, lidocaine, bupivacaine, ropivacaine, opioid analgesics such as buprenorphine, butorphanol, dextromoramide, dezocine, dextropropoxyphene, diamorphine, fentanyl, alfentanil, sufentanil, hydrocodone, hydromorphone, ketobemidone, levomethadyl, levorphanol, meperidine, methadone, morphine, nalbuphine, opium, oxycodone, papaveretum, pentazocine, pethidine, phenoperidine, piritramide, dextropropoxyphene, remifentanil, sufentanil, tilidine, tramadol,
- the bone material may include or be mixed with a therapeutic agent including, but not limited to, an anti-inflammatory agent.
- an anti-inflammatory agent includes, but is not limited to, clonidine, sulindac, sulfasalazine, naroxyn, diclofenac, indomethacin, ibuprofen, flurbiprofen, ketoprofen, aclofenac, aloxiprin, aproxen, aspirin, diflunisal, fenoprofen, mefenamic acid, naproxen, phenylbutazone, piroxicam, meloxicam, salicylamide, salicylic acid, desoxysulindac, tenoxicam, ketoralac, clonidine, flufenisal, salsalate, triethanolamine salicylate, aminopyrine, antipyrine, oxyphenbutazone, apazone, cintazone, flufenamic acid, clonixeril, clo
- Anti-inflammatory agents also include steroids, such as for example, 21-acetoxypregnenolone, alclometasone, algestone, amcinonide, beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol, clobetasone, clocortolone, cloprednol, corticosterone, cortisone, cortivazol, deflazacort, desonide, desoximetasone, dexamethasone, dexamethasone 21-acetate, dexamethasone 21-phosphate di-Na salt, diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, flucloronide, flumethasone, flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone,
- the bone material may include or be mixed with a therapeutic agent including, but not limited to, a statin.
- a statin examples include, but are not limited to, atorvastatin, simvastatin, pravastatin, cerivastatin, mevastatin (see U.S. Pat. No. 3,883,140, the entire disclosure is herein incorporated by reference), velostatin (also called synvinolin; see U.S. Pat. Nos. 4,448,784 and 4,450,171 these entire disclosures are herein incorporated by reference), fluvastatin, lovastatin, rosuvastatin and fluindostatin (Sandoz XU-62-320), dalvastain (EP Application Publication No.
- statin may comprise mixtures of (+)R and ( ⁇ )-S enantiomers of the statin.
- statin may comprise a 1:1 racemic mixture of the statin.
- the bone material can include an antimicrobial agent.
- the antimicrobial agent can include one or more of triclosan, also known as 2,4,4′-trichloro-2′-hydroxydiphenyl ether, chlorhexidine and its salts, including chlorhexidine acetate, chlorhexidine gluconate, chlorhexidine hydrochloride, and chlorhexidine sulfate, silver and its salts, including silver acetate, silver benzoate, silver carbonate, silver citrate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein, and silver sulfadiazine, polymyxin, tetracycline, aminoglycosides, such as tobramycin and gentamicin, rifampicin, bacitracin, neomycin, chloramphenicol, miconazole, quinolones such as oxolinic acid,
- antimicrobial agents include, by way of illustration and not limited to, acedapsone; acetosulfone sodium; alamecin; alexidine; amdinocillin; amdinocillin pivoxil; amicycline; amifloxacin; amifloxacin mesylate; amikacin; amikacin sulfate; aminosalicylic acid; aminosalicylate sodium; amoxicillin; amphomycin; ampicillin; ampicillin sodium; apalcillin sodium; apramycin; aspartocin; astromicin sulfate; avilamycin; avoparcin; azithromycin; azlocillin; azlocillin sodium; bacampicillin hydrochloride; bacitracin; bacitracin methylene disalicylate; bacitracin zinc; bambermycins; benzoylpas calcium; berythromycin; betamicin sulfate; biapenem; bin
- the antimicrobial agent in the bone material can be an antiviral agent that can be mixed with the bone material.
- Antiviral agents can include, but are not limited to, vidarabine, acyclovir, famciclovir, valacyclovir, gancyclovir, valganci clovir, nucleoside-analog reverse transcriptase inhibitors (such as AZT (zidovudine), ddI (didanosine), ddC (zalcitabine), d4T (stavudine), and 3TC (lamivudine)), nevirapine, delavirdine, protease inhibitors (such as, saquinavir, ritonavir, indinavir, and nelfinavir), ribavirin, amantadine, rimantadine, neuraminidase inhibitors (such as zanamivir and oseltamivir), pleconaril, cidof
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Abstract
Description
Claims (14)
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US16/026,574 US10687879B2 (en) | 2018-07-03 | 2018-07-03 | Bone material dispensing device |
CN201980043574.8A CN112351746A (en) | 2018-07-03 | 2019-06-27 | Bone material dispensing device |
AU2019298989A AU2019298989A1 (en) | 2018-07-03 | 2019-06-27 | Bone material dispensing device |
PCT/US2019/039372 WO2020009880A1 (en) | 2018-07-03 | 2019-06-27 | Bone material dispensing device |
EP19831529.3A EP3817680A4 (en) | 2018-07-03 | 2019-06-27 | Bone material dispensing device |
US16/876,828 US11534221B2 (en) | 2018-07-03 | 2020-05-18 | Bone material dispensing device |
US18/088,350 US20230131887A1 (en) | 2018-07-03 | 2022-12-23 | Bone material dispensing device |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US16/026,574 US10687879B2 (en) | 2018-07-03 | 2018-07-03 | Bone material dispensing device |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/876,828 Division US11534221B2 (en) | 2018-07-03 | 2020-05-18 | Bone material dispensing device |
Publications (2)
Publication Number | Publication Date |
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US20200008852A1 US20200008852A1 (en) | 2020-01-09 |
US10687879B2 true US10687879B2 (en) | 2020-06-23 |
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Application Number | Title | Priority Date | Filing Date |
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US16/026,574 Active US10687879B2 (en) | 2018-07-03 | 2018-07-03 | Bone material dispensing device |
US16/876,828 Active 2039-08-09 US11534221B2 (en) | 2018-07-03 | 2020-05-18 | Bone material dispensing device |
US18/088,350 Pending US20230131887A1 (en) | 2018-07-03 | 2022-12-23 | Bone material dispensing device |
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Application Number | Title | Priority Date | Filing Date |
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US16/876,828 Active 2039-08-09 US11534221B2 (en) | 2018-07-03 | 2020-05-18 | Bone material dispensing device |
US18/088,350 Pending US20230131887A1 (en) | 2018-07-03 | 2022-12-23 | Bone material dispensing device |
Country Status (5)
Country | Link |
---|---|
US (3) | US10687879B2 (en) |
EP (1) | EP3817680A4 (en) |
CN (1) | CN112351746A (en) |
AU (1) | AU2019298989A1 (en) |
WO (1) | WO2020009880A1 (en) |
Families Citing this family (1)
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CN115153803B (en) * | 2022-06-23 | 2023-10-17 | 经纬医疗器材制造(深圳)有限公司 | Button-type nail holding pliers |
Citations (15)
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US20020092871A1 (en) | 2001-01-12 | 2002-07-18 | Rickard Thomas A. | Bone cement delivery apparatus and hand-held fluent material dispensing apparatus |
US20040193170A1 (en) | 2003-03-28 | 2004-09-30 | John Kemppainen | Bone graft delivery device and method of use |
US7011238B1 (en) | 2005-09-14 | 2006-03-14 | Kent Bridge Enterprise Co., Ltd. | Adjustable caulk dispensing gun |
US7316689B2 (en) | 2003-04-23 | 2008-01-08 | The Cleveland Clinic Foundation | Apparatus for depositing bone grafting material |
US20100094307A1 (en) | 2001-02-12 | 2010-04-15 | Evans Avery J | Multi-use surgical cement dispenser apparatus and kit for same |
US20110218513A1 (en) | 2010-03-05 | 2011-09-08 | Medicinelodge, Inc. Dba Imds Co-Innovation | Biologics Delivery System |
WO2012151253A1 (en) | 2011-05-02 | 2012-11-08 | Insight Surgical Instruments Llc | Minimally invasive surgical applicator |
WO2013014505A1 (en) | 2011-07-25 | 2013-01-31 | Lameplast S.P.A. | Device for introducing substances inside animals |
US20140257232A1 (en) * | 2013-03-09 | 2014-09-11 | Ebi, Llc | Bone graft delivery apparatus |
US8845646B2 (en) | 2006-03-14 | 2014-09-30 | DePuy Synthes Products, LLC | Apparatus and method for dispensing bone cement |
US20140324013A1 (en) | 2013-04-26 | 2014-10-30 | Medtronic-Xomed, Inc. | Delivery device for graft material |
US20150112352A1 (en) | 2013-10-23 | 2015-04-23 | Stryker Spine | Percutaneous bone graft delivery system and method |
CN105147386A (en) | 2015-09-18 | 2015-12-16 | 北京市富乐科技开发有限公司 | Bone grafting hopper component |
US20160288161A1 (en) | 2015-03-31 | 2016-10-06 | Yongjian YI | Sauce gun with replaceable pushing mechanism |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB2437783B (en) | 2006-04-26 | 2011-11-02 | Summit Medical Ltd | A medical treatment material delivery apparatus |
US10022243B2 (en) | 2015-02-06 | 2018-07-17 | Benvenue Medical, Inc. | Graft material injector system and method |
-
2018
- 2018-07-03 US US16/026,574 patent/US10687879B2/en active Active
-
2019
- 2019-06-27 AU AU2019298989A patent/AU2019298989A1/en active Pending
- 2019-06-27 EP EP19831529.3A patent/EP3817680A4/en active Pending
- 2019-06-27 WO PCT/US2019/039372 patent/WO2020009880A1/en unknown
- 2019-06-27 CN CN201980043574.8A patent/CN112351746A/en active Pending
-
2020
- 2020-05-18 US US16/876,828 patent/US11534221B2/en active Active
-
2022
- 2022-12-23 US US18/088,350 patent/US20230131887A1/en active Pending
Patent Citations (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4338925A (en) | 1979-12-20 | 1982-07-13 | Jo Miller | Pressure injection of bone cement apparatus and method |
US20020092871A1 (en) | 2001-01-12 | 2002-07-18 | Rickard Thomas A. | Bone cement delivery apparatus and hand-held fluent material dispensing apparatus |
US6439439B1 (en) | 2001-01-12 | 2002-08-27 | Telios Orthopedic Systems, Inc. | Bone cement delivery apparatus and hand-held fluent material dispensing apparatus |
US20100094307A1 (en) | 2001-02-12 | 2010-04-15 | Evans Avery J | Multi-use surgical cement dispenser apparatus and kit for same |
US20040193170A1 (en) | 2003-03-28 | 2004-09-30 | John Kemppainen | Bone graft delivery device and method of use |
US7316689B2 (en) | 2003-04-23 | 2008-01-08 | The Cleveland Clinic Foundation | Apparatus for depositing bone grafting material |
US7011238B1 (en) | 2005-09-14 | 2006-03-14 | Kent Bridge Enterprise Co., Ltd. | Adjustable caulk dispensing gun |
US8845646B2 (en) | 2006-03-14 | 2014-09-30 | DePuy Synthes Products, LLC | Apparatus and method for dispensing bone cement |
US20110218513A1 (en) | 2010-03-05 | 2011-09-08 | Medicinelodge, Inc. Dba Imds Co-Innovation | Biologics Delivery System |
WO2012151253A1 (en) | 2011-05-02 | 2012-11-08 | Insight Surgical Instruments Llc | Minimally invasive surgical applicator |
WO2013014505A1 (en) | 2011-07-25 | 2013-01-31 | Lameplast S.P.A. | Device for introducing substances inside animals |
US20140257232A1 (en) * | 2013-03-09 | 2014-09-11 | Ebi, Llc | Bone graft delivery apparatus |
US20140324013A1 (en) | 2013-04-26 | 2014-10-30 | Medtronic-Xomed, Inc. | Delivery device for graft material |
US20150112352A1 (en) | 2013-10-23 | 2015-04-23 | Stryker Spine | Percutaneous bone graft delivery system and method |
EP2865341A1 (en) | 2013-10-23 | 2015-04-29 | Stryker Spine | Percutaneous bone graft delivery system and method |
US20160288161A1 (en) | 2015-03-31 | 2016-10-06 | Yongjian YI | Sauce gun with replaceable pushing mechanism |
CN105147386A (en) | 2015-09-18 | 2015-12-16 | 北京市富乐科技开发有限公司 | Bone grafting hopper component |
Non-Patent Citations (1)
Title |
---|
International Search Report and Written Opinion of the International Searching Authority (ISA/KR) dated Oct. 15, 2019 in International Application No. PCT/US2019/039372 filed on June 27, 2019. |
Also Published As
Publication number | Publication date |
---|---|
US20230131887A1 (en) | 2023-04-27 |
US11534221B2 (en) | 2022-12-27 |
EP3817680A1 (en) | 2021-05-12 |
AU2019298989A1 (en) | 2021-02-25 |
WO2020009880A1 (en) | 2020-01-09 |
EP3817680A4 (en) | 2022-04-06 |
CN112351746A (en) | 2021-02-09 |
US20200008852A1 (en) | 2020-01-09 |
US20200275964A1 (en) | 2020-09-03 |
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